MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. RECOVERY FILTER; VENA CAVA FILTER

Catalog Number RF048F

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Detachment of Device or Device Component (2907); Patient Device Interaction Problem (4001)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for 1 out of 2 malfunctions, therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.For one of the two malfunctions, medical records were provided and reviewed, therefore the investigation is confirmed for filter tilt, perforation and filter limb detachment.Medical record was not provided for another malfunction; therefore, the investigation is inconclusive for the alleged filter limb detachment, perforation and filter tilt as no objective evidence has been provided to confirm any alleged deficiency with the filter.Based on the available information, the definitive root cause is unknown.The devices are labeled for single use.

Event Description

This report summarizes two malfunctions.A review of the reported information indicates that model rf048f vena cava filter allegedly tilted, perforated and struts detached.These reports were received from various sources.Of the two malfunctions, both involved patients with no patient consequences.One patient was female with age (b)(6) years old and weight was not provided.Age, weight and gender for the remaining malfunction was not provided.

Event Description

This report summarizes two malfunctions.A review of the reported information indicates that model rf048f vena cava filter allegedly experienced tilt, perforation and detachment.These reports were received from various sources of the reported two malfunctions, both involved patients with no patient consequences.A 63 years old female and a 58 years old male patients' weight were not provided.

Manufacturer Narrative

H10: of the reported two malfunctions, lot number was provided for one malfunction and the lot history review was performed.The samples were not returned to the manufacturer for inspection/evaluation; however; medical records were provided and reviewed for both the malfunctions.For one malfunction, the investigation is confirmed for the reported filter tilt, perforation and detachment and for the other malfunction, the investigation is confirmed for the reported perforation, detachment but unconfirmed for filter tilt.Based on the available information, the definitive root cause for this event is unknown.The devices are labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: RECOVERY FILTER
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 10305153
• MDR Text Key: 199838680
• Report Number: 2020394-2020-04776
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: RF048F
• Device Lot Number: GFPE3160,UNKNOWN
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/21/2020
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/08/2021
• Patient Sequence Number: 1